(134 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical function of a double lumen endobronchial tube, with no mention of AI or ML capabilities.
No
The device is used to assist in procedures requiring one-lung ventilation by isolating a lung, which is a supportive function during treatment or diagnostic procedures, not a direct treatment for a disease or condition itself.
No
The device description states it is used to intubate the bronchi for lung isolation during procedures, which is a therapeutic rather than a diagnostic function. It is a tool for enabling a medical procedure (one-lung ventilation), not for identifying a condition or disease.
No
The device description clearly states it is a "double lumen endobronchial tube made of polymer materials and inks" and includes physical components like a "y" shape, extensions, and a cuff. This indicates a physical medical device, not a software-only one.
Based on the provided information, the EZ-Blocker is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- EZ-Blocker's Function: The EZ-Blocker is a medical device used in vivo (within the body) to physically isolate a lung for surgical procedures. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for intubating the bronchi to isolate a lung for one-lung ventilation. This is a procedural device, not a diagnostic one.
- Device Description: The description details a physical tube with lumens and cuffs for mechanical manipulation within the airway.
- Lack of IVD Indicators: There is no mention of analyzing samples, reagents, or any other typical components or processes associated with IVD devices.
Therefore, the EZ-Blocker falls under the category of a surgical or procedural medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EZ-Blocker is indicated for use to intubate the patient's bronchi in order to differentially isolate the left or right lung for procedures which require one-lung ventilation, lung separation. Patient population: Patients requiring one lung isolation. Environment of use: Hospitals - OR and ICU.
Product codes (comma separated list FDA assigned to the subject device)
CBI
Device Description
The EZ-Blocker is a double lumen endobronchial tube made of polymer materials and inks. The distal part of the tube ends in a "y" shape with distal extensions for each branch of the lung. The extensions are symmetrical and colored differently (blue and yellow) for identification purposes. The device is supplied with an adapter for connection to a ventilator device. The symmetrical design facilitates introduction and positioning of the device in both main stem bronchi. When properly positioned, the cuff in the main stem branches of the non-ventilated lung can be inflated and lung isolation is achieved.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Bronchi, left or right lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospitals - OR and ICU
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The EZ-Blocker has been tested and confirmed safe under ISO 10993-1 biocompatibility requirements. The assembly is validated for function, leakage, and bond strength. The device is confirmed safe and effective as a device used in standard medical practice.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5740 Tracheal/bronchial differential ventilation tube.
(a)
Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.(b)
Classification. Class II (performance standards).
0
121462
510(k) Summary
-
Submitted by:
EZ-Blocker B.V. Delftechpark 26 Delft 2628 XH The Netherlands -
Contact Person: Lewis Ward L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, CO 80301 303-530-3279
9-14-2012 Date Prepared:
Product: EZ-Blocker
- Classification Name: Tracheal/bronchial differential ventilation tube, Product Code CBI Regulation Number 868.5740
- Intended Use: The EZ-Blocker is indicated for use to intubate the patient's bronchi in order to differentially isolate the left or right lung for procedures which require one-lung ventilation, lung separation.
Technological Characteristics:
The EZ-Blocker is a double lumen endobronchial tube made of polymer materials and inks. The distal part of the tube ends in a "y" shape with distal extensions for each branch of the lung. The extensions are symmetrical and colored differently (blue and yellow) for identification purposes. The device is supplied with an adapter for connection to a ventilator device. The symmetrical design facilitates introduction and positioning of the device in both main stem bronchi. When properly positioned, the cuff in the main stem branches of the non-ventilated lung can be inflated and lung isolation is achieved.
8 2012
1
Substantial Equivalence:
.
| Feature | Cook Inc. Endobronchial
Blocker, K021920 | EZ-Blocker®
This submission |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The 7.0 Fr. Endobronchial
Blocker is intended for use to
differentially intubate a patient's
bronchus in order to isolate the
left or right lung for procedures
which require one-lung
ventilation. | The EZ-Blocker is indicated for
use to intubate the patient's
bronchi in order to differentially
isolate the left or right lung for
procedures which require one-
lung ventilation, lung separation. |
| Company | Cook Inc. | EZ-Blocker B.V. |
| Distal Tip | Single | Double |
| Average Inflation
Volume Range | 2.0 cc – 12.0 cc | Max 12.0 cc (recommended) |
| Balloon | Low-pressure, high-volume
Spherical or Elliptical | Low-pressure, high-volume |
| Lengths | 50, 65, 78 cm | Tubing 69 cm
Overall length 75 cm |
| Materials | Unknown | Silicone, Polyurethane |
| Biocompatibility | Performed but not specified | Cytotoxicity, Sensitization,
Irritation - PASS |
| Testing for verifying
characteristics of the
cuff | - Analysis of cuff pressure at
various inflation volumes
- Analysis of balloon cuff
inflation retention | CMI performed Balloon
Verification Test No. ECO-
00967-002 consisting of:
checking of resting diameter,
leakage, collapsing of balloon,
and burst test. |
| Gas Barrier property | Unknown | CMI has verified by testing that
the balloon retains gas without
significant changes in volume up
to 6 hours after inflation. |
| Packaging | Pouch | Pouch |
| Shelf Life | Unknown | 2 years expiration dated |
.
2
Test Data:
The EZ-Blocker has been tested and confirmed safe under ISO 10993-1 biocompatibility requirements. The assembly is validated for function, leakage, and bond strength. The device is confirmed safe and effective as a device used in standard medical practice.
The EZ-Blocker is substantially equivalent to the Cook Inc. Endobronchial Blocker K021920 based on the performance data.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle emblem. The eagle is depicted with its wings spread, symbolizing protection and service. The overall design is simple and professional, reflecting the department's role in public health and human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
EZ-Blocker B.V. C/O Mr. Lewis Ward President L.W. Ward And Associates, Incorporated 4655 Kirkwood Court Boulder, Colorado 80301
Re: K121462
Trade/Device Name: EZ-Blocker® Regulation Number: 21 CFR 868.5740 Regulation Name: Tracheal/Bronchial Differential Ventilation Tube Regulatory Class: II Product Code: CBI Dated: September 14, 2012 Received: September 17, 2012
Dear Mr. Ward:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2- Mr. Ward
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
hh for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices
Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: EZ-Blocker®
Indications for Use:
The EZ-Blocker is indicated for use to intubate the patient's bronchi in order to differentially isolate the left or right lung for procedures which require one-lung ventilation, lung separation. Patient population: Patients requiring one lung isolation. Environment of use: Hospitals - OR and ICU.
AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) 1
Concurrence of CDRH, Office of Device Evaluation (ODE)
y. Schulten
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K121467